SALDANAR 320 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
VALSARTAN
Available from:
Laboratorios LICONSA, S.A.
INN (International Name):
VALSARTAN
Dosage:
320 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-04-16
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saldanar 320 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 320 mg of valsartan
EXCIPIENTS
Each tablet contains
sorbitol 37.0 mg
lactose 4.3 mg
sodium 1.28 mg (0.06 mmol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oblong, coated, scored on one side, greyish-violet film-coated tablets.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension.
The recommended starting dose of Saldanar is 80 mg once daily. The antihypertensive effect is substantially present
within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not
adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Saldanar may also be administered with other antihypertensive agents. The addition of a diuretic such as
hydrochlorothiazide will decrease blood pressure even further in these patients.
Method of administration
Saldanar may be taken independently of a meal and should be administered with water.
Additional information on special populations
Elderly
No dose adjustment is required in elderly patients.
Renal impairment
No dosage adjustment is required for patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2)
Hepatic impairment
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/04/2011_
_CRN 2058557_
_page number: 1_
In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80
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